Phase 3 1L Study of Pembrolizumab ± Ipilimumab in NSCLC
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind Study of Pembrolizumab plus Ipilimumab vs Pembrolizumab plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)
IRAS ID
233570
Contact name
Tim Benepal
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co.,Inc.
Eudract number
2016-004364-20
Duration of Study in the UK
6 years, 1 months, 27 days
Research summary
Research Summary
In 2008, Lung cancer had the highest incidence of malignancies globally with more than 1.6 million cases. In the same year, mortality from lung cancer was similar with over 1.4 million deaths globally. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases. Progress has been made in the clinical management of early stage NSCLC by establishing comprehensive, multi-modality treatment regimens; however, the prognosis for advanced disease has not improved substantially. With an overall 5-year survival rate of 9% to 13%, the treatment of NSCLC remains a highly unmet medical need.
This is a Phase 3, randomized, double-blind study to evaluate how effective and safe pembrolizumab is in combination with ipilimumab compared with pembrolizumab plus placebo for first-line treatment of patients with previously untreated Stage IV, metastatic NSCLC.
Pembrolizumab (MK-3475) is a highly selective monoclonal antibody designed to directly block PD-1/PDL1 or PD-1/PDL2 interaction. This allows the immune system to increase the immune attack on cancers. Pembrolizumab is currently licenced in Europe for the treatment of melanoma, lung cancer and lymphoma, with trials underway for several other cancers.
Combination immunotherapy offers a potential advantage in patients with NSCLC who may benefit from dual checkpoint blockade. The blocking of PD-1 receptors and CTLA4 receptors results in T-lymphocytes being fully disinhibited.
The study will last approximately 5 years and will recruit 548 men and women older than 18 years. Each participant will take part in the trial for approximately 3 years and will receive up to 35 administrations of pembrolizumab plus 18 cycles of ipilimumab or 35 cycles of pembrolizumab plus 18 cycles of placebo. After the treatment, participants will be followed up for overall survival.
The study is funded by Merck Sharp & Dohme Limited and will take place at 4 study centres in the UK.
Summary of Results
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REC name
London - Central Research Ethics Committee
REC reference
17/LO/1785
Date of REC Opinion
22 Dec 2017
REC opinion
Further Information Favourable Opinion